The present invention generally relates to a container, an access port and a method for establishing flow between the container and an administration set. The access port may establish flow of fluid from the container into an appropriate administration set. More specifically, a valve or base that seals to a container is provided. A perforator or plunger in the valve punctures the container and provides access to the solution in the container.
Containers for the administration of medical solutions are well known. Typically, the containers are made from flexible film that is folded and sealed together along peripheral side edges. Further, the containers typically have an inlet and an outlet. The containers further typically have a device for piercing the outlet and establishing a fluid communication between the device and the solution inside the container. The solution may then be exhausted from the device to an administrative set and/or patient.
Maintaining the sterility of the medical solution to be administered to the patient is extremely important. However, handling of the medical solution container may create risks of contamination. The risk of contamination may increase in emergency situations where quick manipulation on the various components may introduce bacteria or other pathogens into the container. For example, a user may inadvertently touch and/or contaminate a sterile end surface of an inlet or an outlet. The contamination may then be transferred to the contents of the container.
Further, containers for the administration of medical solutions are typically flexible. Accordingly, making a sterile connection to the flexible container for withdrawing the contents in a sterile manner may be difficult. For example, U.S. Pat. No. Re. 29,656 to Chittenden et al. discloses an additive transfer unit having a tubular member that seals to a solution container. The unit includes a needle that punctures a stopper of the solution container. Obtain a liquid-tight and leakproof connection through the flexible container using traditional medical connectors such as, for example, needles or piercing pins is difficult.
Further, administration ports are securely bonded to the flexible container. However, the administrative ports of known flexible solution containers are often the weakest part of the container. Accordingly, certain medical solutions which are sensitive to oxygen and/or other penetrating gases may be compromised. Further, pre-formed administration ports constitute potential sites of leakage and are potential points of contaminant ingress.
Other means for establishing a fluid connection between the container and an administration set are also known. Generally, known access ports require a two-handed operated access port and do not produce audible or visible notification when the access port is fully engaged. Further, many of the known access ports do not substantially protect against touch and air-borne contaminants.
A need, therefore, exists for a formed, filled, sealed solution container with an access port and a method for establishing flow between the container and an administration set. Accordingly, a medical solution container having an improved inlet and outlet port to reduce the likelihood of contamination during storage and/or use is needed. Further, a medical solution container and access port with improved ease of handling is needed. Further still, a solution container and an access port with a liquid tight seal to avoid leaking, minimize touch and/or airborne contamination and minimize permeation of oxygen and/or other gases are needed.